Drug Evaluation Committee Statement from the Data Science Subcommittee of the Drug Evaluation Committee on COVID-19
Data Science Subcommittee
We understand that each company is taking measures in relation to the outbreak of novel coronavirus infection in 2020.
JPMA member companies also need to take measures to prevent the spread of infection, while conducting clinical trials and clinical studies in an appropriate manner.
Problems related to statistical analysis may appear after the clinical trial is in its final stages, and there may be tasks that need to be addressed in statistical analysis planning and data management.
Therefore, the Data Science Subcommittee has summarized possible future problems and measures to deal with them from the viewpoint of statistical analysis and data management, and issued a statement titled "Impact of COVID-19 on Clinical Trials - Statistical Analysis and Data Management Perspectives. We hope that this statement will be widely shared with all parties concerned.
May 11, 2020
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Data Science Subcommittee